The Center for Biosimilars Staff

January 10, 2020

It is the first adalimumab biosimilar approved by the China National Medical Products Administration.

January 09, 2020

The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.

January 09, 2020

The Innovation and Value Initiative (IVI) has updated its existing prototype economic model examining value among rheumatoid arthritis (RA) therapies to include biosimilars.

January 08, 2020

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

January 04, 2020

The findings indicate that interventions that leverage physician relationships may assist with increasing uptake of new, high-value cancer treatments in place of low-value therapies.

January 02, 2020

Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).

December 28, 2019

Autoimmune myasthenia gravis is typically treated with surgery, acetylcholine esterase inhibitors, corticosteroids, and immunosuppressive drugs like azathioprine and mycophenolate mofetil. Some patients have refractory disease and may require therapies like eculizumab (Soliris), which, while effective, is a particularly high-cost biologic that has no approved biosimilars in Europe or the United States, although biosimilars are advancing through clinical development. Rituximab, however, which is lower-cost than eculizumab and has multiple approved biosimilars, has also emerged as a promising treatment.

December 24, 2019

Study findings in patients with rheumatoid arthritis (RA), write the authors, suggest “that potentially more aggressive treatment is needed across the entire population of patients with RA."

December 23, 2019

At 6 months and 1 year, respectively, survival rates among the suboptimal responders who stayed on their index anti–tumor necrosis factor (anti-TNF) agent were 90.2% and 85.1%, respectively.

December 21, 2019

Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.